Efficacy of a Targeted Drug Delivery on-Demand Bolus Option for Chronic Pain.

BACKGROUND AND OBJECTIVES: Intrathecal targeted drug delivery systems historically required physician office visits for dose adjustment to manage fluctuating pain. A wireless device now enables patients to supplement their basal intrathecal infusion with a programmed on-demand bolus dose. We sought to quantify the change in oral breakthrough opioid need associated with the use of an intrathecal bolus in comparison to those treated with the basal infusion alone. METHODS: Demographic, dosage, bolus usage and longevity data were extracted from the historical medical record of 69 patients (18/51 bolus/nonbolus) followed continuously at our center. Medication consumption and Pain Disability Index measures were obtained at baseline and most recent follow-up. RESULTS: Among patients with the bolus option, only 2 (11%; confidence interval [CI] 0% to 26%) continued to require oral opiates to manage breakthrough pain compared to 29 (57%; CI 43% to 71%) without the bolus option. The Pain Disability Index score decreased by 19% in patients with the bolus option and by 25% in those with the basal infusion. Total daily intrathecal opioid intake was 34% lower in the group with the bolus device. CONCLUSIONS: Utilizing an intrathecal bolus to treat incident pain was a safe way to manage unpredictable breakthrough pain and may represent a cost-saving opportunity by eliminating the need for oral analgesic medications.

Spinal Cord Stimulator Related Infections: Findings From a Multicenter Retrospective Analysis of 2737 Implants.

INTRODUCTION: Surgical site infection is a potential complication of spinal cord stimulator (SCS) implantation. Current understanding of the epidemiology, diagnosis, and treatment of these infections is based largely on small clinical studies, many of which are outdated. Evidence-based guidelines for management of SCS-related infections thus rely instead on expert opinion, case reports, and case series. In this study, we aim to provide a large scale retrospective study of infection management techniques specifically for SCS implantation. METHODS: A multicenter retrospective study of SCS implants performed over a seven-year period at 11 unique academic and non-academic institutions in the United States. All infections and related complications in this cohort were analyzed. RESULTS: Within our study of 2737 SCS implant procedures, we identified all procedures complicated by infection (2.45%). Localized incisional pain and wound erythema were the most common presenting signs. Laboratory studies were performed in the majority of patients, but an imaging study was performed in less than half of these patients. The most common causative organism was Staphylococcus aureus and the IPG pocket was the most common site of an SCS-related infection. Explantation was ultimately performed in 52 of the 67 patients (77.6%). Non-explantation salvage therapy was attempted in 24 patients and was successful in resolving the infection in 15 patients without removal of SCS hardware components. DISCUSSION: This study provides current data regarding SCS related infections, including incidence, diagnosis, and treatment.

Spinal Cord Stimulator Implant Infection Rates and Risk Factors: A Multicenter Retrospective Study.

OBJECTIVES: Spinal cord stimulation is an evidence-based treatment for a number of chronic pain conditions. While this therapy offers improvement in pain and function it is not without potential complications. These complications include device failure, migration, loss of therapeutic paresthesia, and infection. This article looked to establish a modern infection rate for spinal cord stimulators, assess the impact of known risk factors for surgical site infections and to determine the impact of certain preventative measures on the rate of infection. METHODS: After institutional review board approval, a multisite, retrospective review was conducted on 2737 unique implants or revisions of SCS systems. Patient demographics, risk factors including diabetes, tobacco use, obesity, revision surgery, trial length, implant location, implant type, surgeon background, prophylactic antibiotic use, utilization of a occlusive dressing, and post-operative antibiotic use were recorded and analyzed. RESULTS: The overall infection rate was 2.45% (n = 67). Diabetes, tobacco use, and obesity did not independently increase the rate of infection. Revision surgeries had a trend toward higher infection rate; however, this did not meet statistical significance. There was no difference in the rate of infection between implants performed by physicians of different base specialties, cylinder leads vs. paddle leads, or between different prophylactic antibiotics. Implants performed at academic centers had a higher rate of infection when compared to implants performed in nonacademic settings. When patients received an occlusive dressing or post-operative antibiotics they had a lower rate of infection. CONCLUSIONS: The infection rate (2.45%) reported in this study is lower than the previously reported rates (3-6%) and are on par with other surgical specialties. This study did not show an increased rate of infection for patients that used tobacco, had diabetes or were obese. It's possible that given the low overall infection rate a larger study is needed to establish the true impact of these factors on infection. In addition, this study did not address the impact of poorly controlled diabetes mellitus (elevated hemoglobin A1c) vs. well-controlled diabetes. It can be concluded from this study that utilizing an occlusive dressing over the incision in the post-operative period decreases the rate of infection and should become the standard of care. This study also demonstrated the positive impact of post-operative antibiotics in decreasing the rate of infection. Studies in other surgical specialties have not shown this impact which would suggest that further research is needed.

Effect of hepatitis B vaccination in patients with chronic hepatitis C.

OBJECTIVE: To assess the effects of hepatitis B vaccination on the antibody titer in patients with chronic hepatitis C and to compare it with response in normal healthy subjects. STUDY DESIGN: Interventional study. PLACE AND DURATION OF STUDY: Shifa International Hospital, Islamabad, Pakistan, from January 2007 to January 2012. METHODOLOGY: Hepatitis vaccination (Heberbiovac-HB 20) was given intramuscularly to the patients of chronic hepatitis C (HCV group) and normal healthy subjects (control group) at 0, 1 and 6 months intervals. Anti-HBs titer was determined after second and third injection to assess the antibody response. RESULTS: There were 46 patients in the HCV group and 45 patients in the control group. Mean age was 40.9 ± 9.8 years in the HCV group and 33.18 ± 8.35 years in the control group. Weight was 67.04 ± 13.5 kg in the HCV group and 71.78 ± 14.63 kg in the control group. Height was 162.45 ± 9.06 cm in the HCV group and 167.03 ± 7.83 cm in the control group. Anti-HBs antibody levels after the second injection were 253.89 ± 76.76 mlU/mL in the HCV group and 245.81 ± 72.65 mlU/mL in the control group (p=0.172). After third injection, the antibody levels were slightly higher in both groups. CONCLUSION: In patients with chronic hepatitis C and normal healthy subjects, Heberbiovac HB in standard dosage gave sero-protective levels in both groups and antibody titers were not significantly different in control and HCV group.

Correlation of hyponatremia with hepatic encephalopathy and severity of liver disease.

OBJECTIVE: To assess the frequency of low serum sodium levels and to correlate it with the severity of liver disease and hepatic encephalopathy (HE) in patients coming to the tertiary care hospital. STUDY DESIGN: Observational study. PLACE AND DURATION OF STUDY: Shifa International Hospital, Islamabad, from January 2011 to January 2012. METHODOLOGY: A total of 202 patients with hepatic encephalopathy and chronic liver disease had serum sodium measured. The HE was graded according to the West Haven classification (4 grades). Relationship of hyponatremia was correlated with severity grade of encephalopathy using Spearman rank correlation test. RESULTS: Out of 202 patients, 62 (30.7%) patients had serum sodium less than 130 meq/l. Out of 202, HE was present in 69 (34.15%) patients and out of these, 38 had grade III-IV HE and 31 had grade I - II HE. Out of 69 patients with HE 57 had sodium less than 135 (p < 0.001). CONCLUSION: Hyponatremia was a common feature in patients with cirrhosis and its severity increased with the severity of liver disease. The existence of serum sodium concentration < 135 mmol/L was associated with greater frequency of hepatic encephalopathy compared with patients with serum sodium concentration > 135 mmol/L.

Treatment of decompensated cirrhosis secondary to hepatitis C with antiviral therapy.

OBJECTIVE: To treat decompensated hepatitis C patient with interferon, ribavirin and amantidine to ascertain the sustained viral response. STUDY DESIGN: Descriptive study. PLACE AND DURATION OF STUDY: Shifa International Hospital, Islamabad, from January 2007 to January 2012. METHODOLOGY: HCV PCR patients with decompensated hepatitis C, who had developed a complication like ascites, encephalopathy or variceal bleeding were included in the study. Those with uncontrolled ascites or other complications were excluded. Treatment with standard interferon 3 miU subcutaneously three times a week along with ribavirin 800 mg to 1200 mg and amantidine 100 mg b.i.d. was administered for 12 months. Patients were followed every month with CBC and ALT and HCV PCR was performed after 3 months to document early viral response. They had HCV PCR at the end of the treatment to document end of treatment response. All were further followed for another 6 months at monthly intervals and HCV PCR was performed at the end of this period to document sustained viral response. RESULTS: In all, 165 patients were treated. Treatment had to be discontinued in 42 (26%) patients. Out of these, 16 patients died. Thus, 123 completed treatment. Sustained viral response was documented in 58 out of the 123 (47%) patients. Hepatic encephalopathy, gastrointestinal bleeding, sepsis and development of ascites were the major complications during treatment. CONCLUSION: Forty seven percent of patients with decompensated hepatitis C cirrhosis were able to achieve sustained viral response after one year treatment with anti-viral therapy. However, complications developed during treatment and, therefore, frequent and close monitoring is necessary in these patients.

Hepatocellular carcinoma after sustained viral response to interferon and ribavirin therapy in cirrhosis secondary to chronic hepatitis C.

OBJECTIVE: To determine the frequency of development of hepatocellular carcinoma in patients with chronic liver disease secondary to hepatitis C who had achieved sustained virological response with Interferon and Ribavirin therapy. STUDY DESIGN: Retrospective descriptive study. PLACE AND DURATION OF STUDY: Shifa International Hospital, Islamabad, Pakistan, from January 2007 to January 2012. METHODOLOGY: Hepatitis C related chronic liver disease patients who were treated with interferon and ribavirin, after they achieved sustained virological response, they were followed for a mean of 42 ± 17 months. During this time, development of hepatocellular carcinoma was ascertained. All underwent surveillance with alpha-feto-protein and ultrasonography every 6 months. RESULTS: Out of the 58 patients who had achieved sustained virological response, 3 developed hepatocellular carcinoma after a mean follow-up of 38 ± 14 months. It was multifocal in 2 cases and was single lesion in the 3rd. Two patients ultimately died, one with upper GI bleeding and the other with hepatic encephalopathy, while 3rd patient with single lesion is still surviving. CONCLUSION: Three out of 58 patients of hepatitis C related chronic liver disease developed hepatocellular carcinoma during follow-up in patients who had achieved sustained virological response. These patients need closer follow-up, for development of complications, even if they have achieved sustained viral response.

Factors affecting patient satisfaction during endoscopic procedures.

OBJECTIVE: To assess the quality and patient satisfaction in Endoscopy Unit of Shifa International Hospital. STUDY DESIGN: Cross-sectional survey. PLACE AND DURATION OF STUDY: Division of Gastroenterology, Shifa International Hospital, Islamabad, Pakistan, from July 2011 to January 2012. METHODOLOGY: Quality and patient satisfaction after the endoscopic procedure was assessed using a modified GHAA-9 questionnaire. Data was analyzed using SPSS version 16. RESULTS: A total of 1028 patients were included with a mean age of 45 ± 14.21 years. Out of all the procedures, 670 (65.17%) were gastroscopies, 181 (17.60%) were flexible sigmoidoscopies and 177 (17.21%) were colonoscopies. The maximum unsatisfactory responses were on the waiting time before the procedure (13.13 %), followed by unsatisfactory explanation of the procedure and answers to questions (7.58%). Overall, unsatisfied impression was 4.86%. The problem rate was 6.22%. CONCLUSION: The quality of procedures and level of satisfaction of patients undergoing a gastroscopy or colonoscopy was generally good. The factors that influence the satisfaction of these patients are related to communication between doctor and patient, doctor's manner and waiting time for the procedure. Feedback information in an endoscopy unit may be useful in improving standards, including the performance of endoscopists.

Uremic cardiomyopathy: an underdiagnosed disease.

Uremic cardiomyopathy is responsible for high morbidity and mortality rates among patients with chronic kidney disease (CKD) or end-stage renal disease (ESRD); however, the early implementation of hemodialysis may halt its progression. Nonconventional hemodialysis, such as frequent hemodialysis, appears to have an advantage over conventional hemodialysis. Kidney transplantation has been shown to reverse uremic cardiomyopathy and to confer a significant survival advantage over hemodialysis. Targeting future therapies at the underlying cellular mechanisms of uremic cardiomyopathy may finally start to reduce the burden of uremic cardiomyopathy in the CKD and ESRD population.